<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04548366293118</udiDi>
    <basicUdiDi>B-04548366293118</basicUdiDi>
    <tradeName>PELNAC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GUNZE LIMITED</manufacturerName>
    <manufacturerSrn>JP-MF-000015551</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M04041002</emdnCode>
    <emdnDescription>ANIMAL-DERIVED COLLAGEN DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN-F40030</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:32:14.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547531515574</udiDi>
    <basicUdiDi>B-04547531515574</basicUdiDi>
    <tradeName>PELNAC</tradeName>
    <deviceName>PELNAC</deviceName>
    <manufacturerName>GUNZE LIMITED</manufacturerName>
    <manufacturerSrn>JP-MF-000015551</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04041002</emdnCode>
    <emdnDescription>ANIMAL-DERIVED COLLAGEN DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN-R82060</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:32:08.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547531515567</udiDi>
    <basicUdiDi>B-04547531515567</basicUdiDi>
    <tradeName>PELNAC</tradeName>
    <deviceName>PELNAC</deviceName>
    <manufacturerName>GUNZE LIMITED</manufacturerName>
    <manufacturerSrn>JP-MF-000015551</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04041002</emdnCode>
    <emdnDescription>ANIMAL-DERIVED COLLAGEN DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN-R82090</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:32:05.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547531515550</udiDi>
    <basicUdiDi>B-04547531515550</basicUdiDi>
    <tradeName>PELNAC</tradeName>
    <deviceName>PELNAC</deviceName>
    <manufacturerName>GUNZE LIMITED</manufacturerName>
    <manufacturerSrn>JP-MF-000015551</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04041002</emdnCode>
    <emdnDescription>ANIMAL-DERIVED COLLAGEN DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN-R82120</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:32:04.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547531515543</udiDi>
    <basicUdiDi>B-04547531515543</basicUdiDi>
    <tradeName>PELNAC</tradeName>
    <deviceName>PELNAC</deviceName>
    <manufacturerName>GUNZE LIMITED</manufacturerName>
    <manufacturerSrn>JP-MF-000015551</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04041002</emdnCode>
    <emdnDescription>ANIMAL-DERIVED COLLAGEN DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN-F82120</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:32:03.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547531515536</udiDi>
    <basicUdiDi>B-04547531515536</basicUdiDi>
    <tradeName>PELNAC</tradeName>
    <deviceName>PELNAC</deviceName>
    <manufacturerName>GUNZE LIMITED</manufacturerName>
    <manufacturerSrn>JP-MF-000015551</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04041002</emdnCode>
    <emdnDescription>ANIMAL-DERIVED COLLAGEN DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN-F82090</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:32:01.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547531515529</udiDi>
    <basicUdiDi>B-04547531515529</basicUdiDi>
    <tradeName>PELNAC</tradeName>
    <deviceName>PELNAC</deviceName>
    <manufacturerName>GUNZE LIMITED</manufacturerName>
    <manufacturerSrn>JP-MF-000015551</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04041002</emdnCode>
    <emdnDescription>ANIMAL-DERIVED COLLAGEN DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN-F82060</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:31:59.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>06223004866579</udiDi>
    <basicUdiDi>B-06223004866579</basicUdiDi>
    <tradeName>Pharmatull</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pharmaplast</manufacturerName>
    <manufacturerSrn>EG-MF-000004501</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M040499</emdnCode>
    <emdnDescription>DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TULL100400</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:05:31.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>08715886028698</udiDi>
    <basicUdiDi>0017276M226M3</basicUdiDi>
    <tradeName>HEKA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ASO LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008641</manufacturerSrn>
    <authorisedRepresentativeName>Aso Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004377</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M04040301</emdnCode>
    <emdnDescription>HYDROCOLLOID DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VH-OT0170-2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-01T14:02:30.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>08715886028728</udiDi>
    <basicUdiDi>0017276M226M3</basicUdiDi>
    <tradeName>HEKA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ASO LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008641</manufacturerSrn>
    <authorisedRepresentativeName>Aso Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004377</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M04040301</emdnCode>
    <emdnDescription>HYDROCOLLOID DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VH-OT0181</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-01T14:02:30.784Z</lastUpdated>
  </row>
  <row>
    <udiDi>08715886028759</udiDi>
    <basicUdiDi>0017276M424M9</basicUdiDi>
    <tradeName>HEKA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ASO LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008641</manufacturerSrn>
    <authorisedRepresentativeName>Aso Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004377</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M04040301</emdnCode>
    <emdnDescription>HYDROCOLLOID DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VH-OT0172</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-01T14:02:30.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>08715886028780</udiDi>
    <basicUdiDi>0017276M226M3</basicUdiDi>
    <tradeName>Heka</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ASO LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008641</manufacturerSrn>
    <authorisedRepresentativeName>Aso Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004377</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M04040301</emdnCode>
    <emdnDescription>HYDROCOLLOID DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VH-OT0174</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-01T14:02:30.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>08715886028810</udiDi>
    <basicUdiDi>0017276M226M3</basicUdiDi>
    <tradeName>HEKA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ASO LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008641</manufacturerSrn>
    <authorisedRepresentativeName>Aso Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004377</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M04040301</emdnCode>
    <emdnDescription>HYDROCOLLOID DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VH-OT0176</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-01T14:02:30.700Z</lastUpdated>
  </row>
  <row>
    <udiDi>08715886028841</udiDi>
    <basicUdiDi>0017276M226M3</basicUdiDi>
    <tradeName>HEKA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ASO LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008641</manufacturerSrn>
    <authorisedRepresentativeName>Aso Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004377</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M04040301</emdnCode>
    <emdnDescription>HYDROCOLLOID DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VH-OT0195</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-01T14:02:30.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>08715886028872</udiDi>
    <basicUdiDi>0017276M226M3</basicUdiDi>
    <tradeName>HEKA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ASO LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008641</manufacturerSrn>
    <authorisedRepresentativeName>Aso Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004377</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M04040301</emdnCode>
    <emdnDescription>HYDROCOLLOID DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VH-OT0198</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-01T14:02:30.608Z</lastUpdated>
  </row>
  <row>
    <udiDi>00705928652057</udiDi>
    <basicUdiDi>B-00705928652057</basicUdiDi>
    <tradeName>NeilMed Neilcleanse Piercing Aftercare Fine Mist</tradeName>
    <deviceName>NeilMed Neilcleanse Piercing Aftercare</deviceName>
    <manufacturerName>NeilMed Pharmaceuticals Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000025412</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04040101</emdnCode>
    <emdnDescription>SALINE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6095ST-FRN-INT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:07:16.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>00704411018950</udiDi>
    <basicUdiDi>B-00704411018950</basicUdiDi>
    <tradeName>AMSure® Sterile Water</tradeName>
    <deviceName>Sterile Water, and Sterile Normal Saline for Wound Flush</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04040101</emdnCode>
    <emdnDescription>SALINE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS399K-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:06:54.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>00704411018943</udiDi>
    <basicUdiDi>B-00704411018943</basicUdiDi>
    <tradeName>AMSure® Sterile Water</tradeName>
    <deviceName>Sterile Water, and Sterile Normal Saline for Wound Flush</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04040101</emdnCode>
    <emdnDescription>SALINE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS399K</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:06:51.950Z</lastUpdated>
  </row>
  <row>
    <udiDi>00704411018936</udiDi>
    <basicUdiDi>B-00704411018936</basicUdiDi>
    <tradeName>AMSure® Sterile Normal Saline</tradeName>
    <deviceName>Sterile Water, and Sterile Normal Saline for Wound Flush</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04040101</emdnCode>
    <emdnDescription>SALINE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS398K-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:06:49.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>00704411018929</udiDi>
    <basicUdiDi>B-00704411018929</basicUdiDi>
    <tradeName>AMSure® Sterile Normal Saline</tradeName>
    <deviceName>Sterile Water, and Sterile Normal Saline for Wound Flush</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04040101</emdnCode>
    <emdnDescription>SALINE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS398K</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:06:49.008Z</lastUpdated>
  </row>
</eudamedExport>